Study Design

Study Design:

Patient Populations:

Exclusions:

Contraindications to anticoagulation, including those at high risk of bleeding; receiving oral anticoagulants; or with creatinine levels >265.2 mg/dl

Drug/Procedures Used:

Patients were randomized to an infusion of GIK or control (no infusion).

In a factorial design, patients were also randomized to either fondaparinux (2.5 mg/d for up to 8 days or hospital discharge; n = 6,036) or control (n = 6,056).

Principal Findings:

The GIK portion of the OASIS-6 trial was discontinued early after enrollment of 2,748 patients due to the negative results of the CREATE-ECLA trial, which showed no difference between GIK and control in STEMI patients. Likewise, results of the OASIS-6 – GIK trial were also negative. There was no difference in the composite of death or heart failure at 30 days between the GIK and control groups (14.3% for GIK vs. 15.4% for control, p = NS) or in the individual components of death (7.6% for GIK vs. 6.7% for control, hazard ratio [HR] 1.14, p = 0.36) or heart failure (10.6% for GIK vs. 12.2% for control, p = NS).

In a combined analysis of data from both the CREATE-ECLA and OASIS-6 GIK trials (n = 11,462 for GIK and n = 11,481 for control), there was no difference in 30-day death (HR 1.04, p = 0.36), heart failure (HR 1.02, p = 0.62) or death/heart failure (HR 1.01, p = 0.78).

Interpretation:

Among patients with STEMI, treatment with a GIK infusion was not associated with a difference in 30-day death, heart failure, or the composite of the two compared with control.

Despite the promising findings of a meta-analysis of previous small studies that suggested that high-dose GIK may reduce mortality, the present study of GIK along with the more than 20,000 patients in the CREATE-ECLA – GIK trial, showed no difference in mortality or heart failure.

References:

Presented by R. Diaz, European Society of Cardiology Scientific Congress, September 2006.